BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20

K192515 · Shenzhen Bioeasy Biotechnology Co., Ltd. · LDJ · Oct 11, 2019 · Clinical Toxicology

Device Facts

• Record ID: K192515
• Device Name: BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
• Applicant: Shenzhen Bioeasy Biotechnology Co., Ltd.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Oct 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Indications for Use

BIOEASY Marijuana Test Dip Card 40 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 40 ng/mL. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. BIOEASY Marijuana Test Strip 40 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 40 ng/mL. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. BIOEASY Marijuana Test Dip Card 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. BIOEASY Marijuana Test Strip 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

Device Story

Single-use, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine; prescription use. Device formats include dip cards and test strips. Principle: competitive binding; urine specimen migrates via capillary action; target drug below cutoff allows antibody-coated particles to bind immobilized drug-conjugate, forming visible line; drug above cutoff saturates binding sites, preventing line formation. Control line indicates proper test performance. Used in clinical settings; operated by healthcare professionals. Provides preliminary results; requires confirmatory testing (GC/MS or LC/MS) for clinical decision-making. Benefits: rapid, preliminary screening for marijuana presence.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (n=60 per concentration level per lot) and method comparison studies (n=80 clinical samples per format) against LC/MS reference method. Evaluated interference from physiological/pathological substances, cross-reactivity, and effects of urine pH/specific gravity. No clinical studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Form factors: dip card and test strip. Analyte: Marijuana (11-nor-Δ9-THC-9-COOH). Cutoffs: 20 ng/mL and 40 ng/mL. Stability: 24 months at 4-30°C. No electronic components, software, or connectivity.

Indications for Use

Indicated for qualitative detection of Marijuana in human urine for prescription use. Cutoff concentrations are 20 ng/mL or 40 ng/mL. Results are preliminary; requires confirmation via GC/MS or LC/MS.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: k192515

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.